Approval

One essential requirement for operating successfully on any market is to always stay up to date with the latest legal restrictions or necessary certifications for your business segment.

This working group’s main task is to have a close look at the current status quo in order to define what is needed to gain approval for 3D-printed medical devices and to establish them in the industry.

To achieve this, we concentrate on the following topics:

European Medical Device Regulation (MDR): Converting old standards into new standards (norms, liability, certification)

Jointly overcoming regulatory hurdles in the certification process

Leveraging know-how transfer by inviting specialists in MDR, quality management, end-to-end solutions, point-of-care manufacturing, cost management, etc.

Dr. Cora Lüders-Theuerkauf

Network Manager Medical

Simon Schlagintweit

Medical Expert & Lead Auditor

TÜV Süd Production Service GmbH

Approval events

No Events

 

Approval news

MGA Medical Working Group Approval Result: MDR Decision Tree

Prüfverfahren 3D-gedruckter Medizinprodukte

The following are involved in the Approval working group

3D Systems

Additive Industries

Covestro

DMRC

DYE Mansion

Eos

ExOne

Expertants

FIT

Gefertec

GMH Gruppe

Hachtel

Hofmann

HP

iGo3D

materialise

simufact

Tüv Süd

Ultimaker

More Medical goes Additive Working Groups

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